In day 7 of his hunger strike, Chronic Fatigue Syndrome patient Robert Miller decried FDA’s decision to disapprove Ampligen, the only medication in clinical trial for him and a million ill Americans. Mr. Miller is asking Secretary of Health Kathleen Sebelius to conduct clinical trials of Ampligen at the National Institutes of Health.

Because there is NO FDA-approved medication for CFS, and none in the pipeline, FDA’s decision forecloses any potential of an approved medicine for patients for years to come. Given the serious, life-threatening nature of CFS, as acknowledged by FDA, this denial creates an obligation for the Department of Health and Human Services and NIH to fill the 25-year void in drug development.

Dr. Nancy Klimas, one of the nation’s top CFS clinicians, stated in a statement , “The data shows that a subgroup of CFS/ME patients showed marked improvement, even recovery on the drug.” Until last year, Dr. Klimas was a member of the Secretary of Health's Chronic Fatigue Syndrome Advisory Committee.

Miller has been on Ampligen since 1999, and moved his family twice in 14 years to access the clinical trial. “Now the 100 or so patients on Ampligen like me risk losing the only treatment that clearly works for us. Ampligen transforms me from bedridden to being able to care for my twin boys.”

NIH promotes its ability to conduct clinical trials, and it has proudly launched the National Center for Translational Science to “bridge basic science and human medicine” and accelerate the process for developing therapeutics. “It is the perfect place to pursue larger clinical trials of Ampligen to understand how to identify responders and learn from the mechanism of the drug on patient’s immune systems. Imagine what we could learn,” said Miller.

Cleve Jones, founder of the AIDS Quilt, noted: “CFS patients suffer without any treatments, and I can remember those days in my life. I urge Secretary Sebelius to apply what we learned with HIV about getting treatments to untreated patients like every minute counts.”

Anita Patton, a CFS patient who has been on and off Ampligen at different times over 15 years, was outraged. Last year, Patton was in a wheelchair, unable to prepare her own meals. “After a year of Ampligen, I have my life back. I was there at the December hearing, where the FDA staff listened to my story and turned to the Advisory Panel and said Ampligen doesn’t work.”

Thousands petitioned FDA for Ampligen’s approval.

Last fall, President Obama urged Secretary Sebelius to “elevate CFS in priority at HHS,” following a promise he made to my wife Courtney at a Reno Town Hall meeting. The first act of the President’s second administration on CFS is to reject this only medicine.

CFS affects 1 million Americans, costs our government $20 billion annually, and disables approximately 25% of patients, according to peer-reviewed research. FDA’s objections center on the lack of clear biomarkers to measure effectiveness of Ampligen. The absence of those biomarkers is the result of negligible research by the NIH into abnormalities of the disease, amounting to a measly $6 million per year.